Chronic Kidney Disease Clinical Trial
— CONFUCIUSOfficial title:
Estimating the Contribution of Renal Function to Endothelial Dysfunction by a Two-cohort Study: Living Kidney Donors and Their Transplant Recipients
Endothelial dysfunction one-year after transplantation mainly depends on
transplant-associated factors and only marginally on reduced renal function.
OBJETIVES Primary objective Estimate the contribution of renal dysfunction to endothelial
dysfunction in two cohorts of patients, living kidney donors and their transplant
recipients.
Secondary objectives
To evaluate in both cohorts of patients before and after nephrectomy/transplantation the
evolution of the following parameters:
1. Renal function (iohexolGFR, proteinuria/microalbuminuria).
2. Blood pressure (24 h ambulatory blood pressure measurement)
3. Surrogate variables of subclinical atherosclerosis (carotid ultrasound, ankle-brachial
index, pulse wave velocity).
DESIGN Non-interventional, prospective, multicenter, longitudinal study of two cohorts:
living kidney donors and their transplant recipients.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria cohort 1: - No history of familiar nephropathies and/other diseases that may increase the risk for renal disease in the future. - Donor age = 18 years - Isotopic GFR > 80 ml/min/1.73m2 - Microalbuminuria< 30 mg/g - Normal urinary sediment - Normal blood pressure defined as <120/90 mmHg and without other risk factors for cardiovascular disease, and with good/normal kidney function or well-controlled hypertension with one anti-hypertensive drug, - No previous history of diabetes including gestational diabetes and fasting glucose < 126 mg/dl and 2h serum glucose after 75 g oral glucose tolerance test < 200 mg/dl - Signed informed consent Inclusion criteria cohort 2: - Chronic kidney disease stage 5 - Negative complement dependent lymphocytotoxicity donor-recipient cross-match. - Informed signed consent Exclusion Criteria cohort 1: - History of cancer except non-melanoma cutaneous neoplasia - History of vasculitis (e.g. lupus), sarcoidosis, gastrointestinal inflammatory diseases, autoimmune-disease - History of major cardiovascular events - History of deep vein thrombosis or pulmonary embolism. - Active infection including hepatitis B, C and HIV infections. - Anatomic vascular variants precluding laparoscopic nephrectomy - Renal stones except a solitary lithiasis< 1.5 cm once metabolic disorders are ruled out - Major psychiatric disorders - Active alcohol, tobacco or drug abuse - Obesity defined as body mass index > 35 kg/m2. - Pregnancy Exclusion criteria cohort 2: - Glomerulonephritis with high recurrence rate after transplantation (focal segmental glomerulosclerosis and type II membranoproliferative glomerulonephritis) - Severe aortoiliac atherosclerosis precluding transplantation - Major psychiatric disorders - Alcohol and drug abuse - Active infection - Patients requiring desensitization treatment before transplantation. - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital del Mar | Barcelona | |
Spain | Vall d'Hebron Research Institute | Barcelona | |
Spain | Hospital Regional Universitario Carlos Haya | Malaga | |
Spain | Hospital Universitario Canarias | Santa Cruz de Tenerife | Islas Canarias |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Vall d'Hebron Research Institute | Teva Pharmaceutical Industries, Ltd. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentual change of sVCAM | Biomarker of endothelial dysfunction: Soluble VCAM (vascular cell adhesion molecule). Determination of serum levels by Luminex. Percentual change between baseline and 1 year levels. | 1 year | |
Secondary | Glomerular filtration rate | Renal function will be estimated before donation by iohexol clearance and expressed as mL/min/1.73 m2 in donors and at 1 year in donors and recipients. | 1 year | |
Secondary | Microalbuminuria | Microalbuminuria (mg/g creatinine) will be determined before donation and at 1 year in donors and at 1 year in transplant recipients. | 1 year | |
Secondary | Blood pressure (24 h ambulatory blood pressure measurement) | Ambulatory blood pressure monitoring (mm Hg) with overnight-automated ABPM monitor (Spacelab 90207; Spacelabs Healthcare,USA) with appropriate cuff sizes for each patient. | 1 year | |
Secondary | Number of carotid plaques and carotid intima-media thickness | Atherosclerotic burden: carotid ultrasound to determine the number of plaques and intima-media thickness will be held in both carotid arteries with a high-frequency (8-12 MHz) linear transducer (ESAOTE, 7300, Florence, Italy), | 1 year | |
Secondary | Pulse wave velocity. | Carotid-femoral pulse wave velocity (m/s) will be measured by pulse tonometry (Sphingmocor Atcor, EM3, Australia). | 1 year | |
Secondary | Percentual change of sICAM | Biomarker of endothelial dysfunction: Soluble ICAM (intercellular adhesion molecule). Determination of serum levels by Luminex. Percentual change between baseline baseline and 1 year levels. | 1 year | |
Secondary | Percentual change of PECAM | Biomarker of endothelial dysfunction: PECAM (platelet/endothelial cell adhesion molecule). Determination of serum levels by Luminex. Percentual change between baseline baseline and 1 year levels. | 1 year | |
Secondary | Percentual change of vWF | Biomarker of endothelial dysfunction: vWF (von Willebrand factor). Determination of serum levels by Luminex. Percentual change between baseline baseline and 1 year levels. | 1 year | |
Secondary | Percentual change of E-selectin | Biomarker of endothelial dysfunction: Soluble E-selectin. Determination of serum levels by Luminex.Percentual change between baseline baseline and 1 year levels. | 1 year | |
Secondary | Percentual change of PTX3 | Biomarker of endothelial dysfunction: PTX3 (pentraxin). Determination of serum levels by ELISA. Percentual change between baseline baseline and 1 year levels. | 1 year | |
Secondary | Percentual change of hs-CRP | Biomarker of subclinical inflammation: hs-CRP (high sensitive C reactive protein). Determination of serum levels by nephelometry. Percentual change between baseline baseline and 1 year levels. | 1 year | |
Secondary | Percentual change of IL-6 | Biomarker of subclinical inflammation: IL-6 IL-6 (interleukin 6). Determination of serum levels by Luminex. Percentual change between baseline baseline and 1 year levels. | 1 year | |
Secondary | Percentual change of sTNFR1 and sTNFR2 | Biomarker of subclinical inflammation: sTNFR1 and sTNFR2 (soluble tumor necrosis factor receptor). Determination of serum levels by Luminex. Percentual change between baseline baseline and 1 year levels. | 1 year | |
Secondary | Percentual change of sTWEAK | Biomarker of subclinical inflammation: sTWEAK (soluble TNF-like weak inducer of apoptosis). Determination of serum levels by ELISA. Percentual change between baseline baseline and 1 year levels. | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
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